HPLC assay method validation of tablet | Repetability Section

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REPEATABILITY:
flowchart of hplc
FIG: HPLC

Aim:

To determine the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogenous sample.

Method:

1.    Using test method, prepare 6 sample solutions and record the accurate sample weights.
2.      The assay according to a method, injecting each sample solution in duplicate.
3.      Calculate the content of each sample as % and determine the mean and % RSD.

Acceptance Criteria:
The % RSD of the standard content of replicate (Six) samples must not exceed 2%.


Results:

(Name of Tablet )   ___mg  -    batch _____ (if available)
Sample No.
Active Ingredient (%)
1

2

3

4

5

6

Mean

SD

%RSD



Conclusion:
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________


Performed by:_______________                      Checked by:_______________
(Sign/Date)                                                      (Sign/Date)

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